Oversight from FDA at pharma manufacturing sites dipped during 2021 pandemic
The FDA completed less than half (48%) of its regulatory actions for pharma facilities designated as OAI or with an Official Action Indicated, within 6 months of an inspection closing, according to the latest report from the agency on the effects Covid-19 had on general oversight at manufacturing sites last year.
The agency also lost pace in issuing final facility classification letters.
In FY 2021, the report noted FDA issued 70% of final facility classification letters within 90 days of inspection closing. By comparison, in FY 2019, 87% of final facility classification letters were issued within 90 days of inspection closing, and completed 74% of regulatory actions for OAI facilities.
Pandemic mitigation efforts such as travel restrictions have impacted the number of inspections conducted by the FDA as resources were being diverted to the pandemic response.
The backlog at the FDA has been well documented. In 2021, the Government Accountability Office detailed that the FDA did not conduct any new in-person inspections of Covid-19 vaccine manufacturing plants before issuing the EUAs for Pfizer, Moderna and J&J’s shots. Meanwhile, the agency instead had to rely on historical findings for the 18 manufacturing sites.
While the FDA issued measures on conducting virtual evaluations to get a handle on the backlog, there were still major limitations to the remote program, and it only filled a fraction of the inspections in the agency’s backlog.
The numbers for 2022 will most likely not improve too much as even earlier this year, the FDA quietly announced it once again paused all its non-mission-critical inspections in the US, but those inspections have since returned to normal.
Although more inspections, Form 483s, and warning letters are starting to roll out again, the agency has a lot of catching up to do if it wants to return to pre-pandemic levels.
